Condensyl® and decreases sperm DNA damage which is a risk factor for male infertility: evaluation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006

摘要

Following an application from Laboratoire Nurilia submitted for authorisation of a health claim pursuant\udto Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of France, the EFSA Panel on\udDietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific\udsubstantiation of a health claim related to ‘Condensyl® and decreases sperm DNA damage. High sperm\udDNA damage is a risk factor for male subfertility/infertility’. Condensyl® is a fixed combination of opuntia\udfruit dry extract, N-acetyl cysteine, zinc, nicotinamide, vitamins B2, B6, B12 and E, and folic acid. The\udPanel considers that Condensyl® is sufficiently characterised. The Panel assumes that the disease that is\udthe subject of the application is male infertility and that the target population for the claim includes\udmales wishing to increase their fertility but excludes males with clinical infertility. The Panel considers\udthat the reduction of DNA sperm damage is a beneficial physiological effect in the context of reducing\udthe risk of male infertility. The applicant provided four human intervention studies conducted in males\udwith clinical infertility, from which no conclusions could be drawn for the scientific substantiation of the\udclaim. The Panel concludes that a cause and effect relationship has not been established between the\udconsumption of Condensyl® and reduction of DNA sperm damage in the context of reducing the risk of\udmale infertility.